Description

Plerixafor Impurity 38 is a designated reference standard used in the analytical profiling and quality control of Plerixafor, a pharmaceutical agent. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a known benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of Plerixafor-based therapies.

Application

• Pharmaceutical Reference Standard: Serves as a critical benchmark for the identification and quantification of impurities in Plerixafor API during HPLC and LC-MS analysis.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control (QC) Testing: Used in routine QC testing of Plerixafor drug substance and drug product batches to ensure compliance with specified impurity limits.
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Plerixafor Impurity 38
CAS No.	170161-29-2
Molecular Formula	C₂₈H₅₄N₈
Molecular Weight	494.79 g/mol
Synonyms	1,1'-[1,4-Phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane]; AMD3100 Impurity 38; JM 3100 Impurity; 1,1'-[1,4-Phenylenebis(methylene)]bis-1,4,8,11-tetraazacyclotetradecane; Plerixafor Related Compound 38; Bicyclam Impurity 38
EINECS	Contact for details

Quality Control

Our Plerixafor Impurity 38 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via NMR and MS, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. The container should be sealed under inert atmosphere after each use to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.